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Measuring Smoking Behaviors While Using Varenicline

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00948155
First received: July 28, 2009
Last updated: April 1, 2011
Last verified: April 2011
History of Changes
  Purpose

This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.


Condition Intervention Phase
Nicotine Dependence
 Drug: Varenicline (Chantix)
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Smoking Topography and Behaviors During Response to Varenicline

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • The smoking topography measures of most interest are: 1) total puff volume, 2) mean puff velocity, and 3) daily cigarette consumption as behavioral measures of smoke exposure and evidence of compensatory smoking. [ Time Frame: Days 1-21 of each of 2 study periods ] [ Designated as safety issue: No ]
  • The cigarette choice paradigm has one outcome measure: the frequency of nicotine cigarette choices, relative to the de-nicotinized cigarette. We will examine differences by study day and treatment type (varenicline v. placebo) for this outcome measure. [ Time Frame: Days 1, 7, 21 of each of two 21 day study periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary nicotine and cotinine levels [ Time Frame: Days 1, 7, 21 of each of two 21 day study periods ] [ Designated as safety issue: No ]
  • Subjective measures to assess smoking urges, withdrawal symptoms, effects of smoking. [ Time Frame: Days 1, 7, 21 of two 21 day study periods ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Varenicline (Chantix)
    Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bidaily days 4-7; 1.0 mg bidaily days 8-21.
    Other Name: Chantix
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • self report minimum 10 daily cigarettes
  • self report smoking every day past 5 years
  • between the ages 21-65
  • self report intention to try to quit smoking in the next 6 months

Exclusion Criteria:

  • self reported use of any nicotine-containing products other than non-menthol cigarettes
  • self reported history or current treatment of substance abuse (other than nicotine dependence)
  • self reported alcohol use greater than 25 standard drinks per week;
  • currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy screen)
  • self reported history or current diagnosis of any Axis 1 disorders except past depression
  • self reported serious or unstable disease within past year
  • self reported history of epilepsy or seizure disorder;
  • self reported history or current diagnosis of COPD, cardiovascular disease, heart attack, or uncontrolled hypertension
  • self reported kidney function impairment
  • any current or recent (30 day) use of: smoking cessation medications, anti-psychotics, anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing medications
  • less than 5 years of daily smoking
  • any medical condition or concomitant medication that could compromise participant safety or treatment
  • provide a baseline CO reading < 10 ppm
  • self reported use of non filtered cigarettes
  • inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948155

Locations
United States, Pennsylvania
Tobacco Use Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Pfizer
Investigators
Principal Investigator: Andrew Strasser, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Andrew Strasser, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00948155     History of Changes
Other Study ID Numbers: 808930
Study First Received: July 28, 2009
Last Updated: April 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
smoking
nicotine
varenicline

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits
Varenicline
Nicotinic Agonists
 Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013